Quality Executive

Location
Kent
Salary
£0 per annum
Posted
06 Jul 2017
Closes
03 Aug 2017
Ref
J4003
Contact
William Blohm
Contract Type
Permanent
Hours
Full Time
Job Description:

We are currently looking for a Quality Executive to join a leading company based in the Kent area. As the Quality Executive you will be responsible for

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Quality Executive will be varied however the key duties and responsibilities are as follows:

- To assist the Quality Assurance Manager and other QA team members in implementation of the Quality System at our different sites.

- To work with all necessary departments to ensure the GMP and the GACP system is current and in compliance with the current guidelines and company filings.

- To review and work to continuously improve compliance within our facilities through promoting QA and developing sustainable quality systems as directed by Senior Quality Assurance Executives (SQAE) and quality management team.

ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the Quality Executive we are looking to identify the following on your profile and past history:

- The job holder is responsible for maintaining cGxP and EHS knowledge applicable to the job.
- Reviewing of batch records or, validation documentation, ensuring they are clear, complete and in compliance with company procedures, regulatory requirements, marketing partner requirements and GMP requirements prior to QP review and release. To achieve agreed average review times.
- Leading and assisting in departmental investigations including Deviations, OOS, OOE, OOT and complaints, ensuring they are fully documented, appropriately root caused and corrective and preventative actions have been introduced or, initiated.
- Day to day training, mentoring and supporting of more junior members of the department
- Support the regular review and development of the Quality Systems within the area of specialism as required by ICH Q10 to ensure the systems and procedures are compliant with cGMP standards.
- Monitoring and continuously improving quality metrics (KPI) pertinent to area of specialism. Assisting in the achievement of acceptable levels of performance through training, regular area visits and influencing others in all departments on site.
- Assist or lead audits (external and internal) as required
- Monitoring and auditing of Contract manufacturing organisations (CMO's) working with our site quality management
- The job holder is responsible to ensure they understand the health, safety, security and environmental protection in their departments and the areas they visit as part of their role.
- Author, review SOP's, validation protocols, file notes, deviations and other quality documents.

DETAILED RESPONSIBILITIES

- Prepares, reviews, updates and completes Quality Management System documentation (e.g. OOS investigations, deviations, CAPAs, change controls) and validation documentation.
- Performing the review of batch records or validation documentation for the areas of Botanical Drug Substance (BDS), pure API, commercial product and investigational medicinal products as required
- Providing QA technical support in area of specialism including line checks and area clearances as required by CTS, PDMF, pharmaceutical R&D and BDP areas
- Ensuring that regulatory, marketing partner, Due Diligence and other audits/inspections performed are supported with efficient document retrieval and supply of technical information.

Ensuring all investigations which could lead to recall are immediately brought to the attention of the SQAE, QP's and Quality management team.

- Education to degree standard, in a scientific or quality systems discipline or, good experience from vocational training
- Risk assessment/HACCP trained
- Good experience in a growing or pharmaceutical environment essential
- Previous experience within food growing production or pharmaceutical plant production essential
- Knowledge and understanding of documentation i.e. work instructions, test methods and process methods
- Driving license essential
- Knowledge of Quality Management systems Global GAP or GACP
- Good experience working in an EU regulated pharmaceutical manufacturing site in a quality role is essential.

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